The Food and Drug Administration has reversed its opposition to UniQure’s Huntington’s disease treatment, clearing the company to file for U.S. approval of AMT-130. The company said on Wednesday that it now plans to submit a marketing application in the third quarter.

That turns a regulatory fight into a filing calendar. For investors watching Qure stock, the shift matters because it opens the door to accelerated approval, the faster path that can let a drug reach the market before a full final dataset is complete if the agency accepts earlier evidence of benefit.

UniQure said the FDA agreed that a three-year analysis from an early-stage study was acceptable to support the application. In plain terms, the company is relying on a longer look at patient outcomes rather than a short snapshot, and the agency is now willing to review that package. The same data had not been enough for former FDA officials Marty Makary and Vinay Prasad, who had previously concluded it was insufficient to support a marketing application.

That earlier judgment is what made the reversal notable. The dispute was never over whether AMT-130 was an experimental treatment for Huntington’s disease; it was over whether the evidence on hand had enough weight to justify a filing. Former officials saw a gap. The FDA, after meeting with the company, decided the gap was narrow enough to cross.

For UniQure, the immediate consequence is simple: it can move ahead with the paperwork and try to make its case for accelerated approval. For everyone else following Qure stock, the next milestone is the third-quarter submission, which will show whether the agency’s new position holds once the full application is in front of it.